Method of preparing a balloon dilatation catheter

• US 5,315,747 A
• Filed: 10/30/1992
• Issued: 05/31/1994
• Est. Priority Date: 10/30/1992
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Pameda N.V.
• Inventors: Solar, Ronald J.
• Primary Examiner(s): Rosenbaum, Mark
• Assistant Examiner(s): Bryant, David P.
• Application Number:
  US07/969,946
• Time in Patent Office: 578 Days
• Field of Search: 29/447, 285/381, 403/273, 156/85, 156/86, 156/84, 128/DIG. 18, 264/230, 264/573, 264/DIG. 71
• US Class Current: 29/447
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: Y10S 128/18 Heat shrinkable film
• CPC Class Codes: Y10S 264/71 Processes of shaping by shrinking
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]

Abstract

This invention relates to the preparation of a balloon dilatation catheter which comprises blowing a length of double lumen tubing to produce a double lumen catheter piece having distal and proximal ends and having a first lumen and a second lumen; cutting an opening in the second lumen proximal to the distal end of the catheter piece; inserting a pushing wire having distal and proximal ends into the second lumen through the proximal end of the catheter piece until the distal end of the pushing wire extends distally across the opening; inserting a piece of lubricous tubing into the second lumen through the distal end of the catheter piece; sealing the distal end of the first lumen; heating the distal portion of the catheter piece to cause the distal portion of the second lumen to shrink slightly to cause the lubricous tubing to fixedly engage the distal end of the pushing wire, while the first lumen is pressurized; and heating the remainder of the catheter piece to cause the second lumen to shrink around the pushing wire and the first lumen to shrink to define a balloon.

Claims

1. A method of preparing a balloon dilatation catheter which comprises the steps of:

(a) blowing a length of multiple lumen tubing to produce a double lumen catheter piece having distal and proximal ends and having a first lumen and a second lumen;

(b) cutting an opening in the second lumen proximal to the distal end of the catheter piece;

(c) inserting a pushing wire having distal and proximal ends into the second lumen through the proximal end of the catheter piece until the distal end of the pushing wire extends distally across the opening;

(d) inserting a piece of lubricious tubing having proximal and distal ends proximally into the second lumen through the distal end of the catheter piece so that the proximal end of the lubricious tubing overlaps the distal end of the pushing wire;

(e) sealing the distal end of the first lumen;

(f) heating the distal portion of the catheter piece to cause the distal portion of the second lumen to shrink slightly to cause the lubricious tubing to fixedly engage the distal end of the pushing wire, while the first lumen is pressurized to prevent shrinkage of the distal portion thereof; and

(g) heating the remaining portion of the catheter piece to cause the second lumen to shrink around the pushing wire and the first lumen to shrink to define a balloon at the distal end thereof.

2. The method of claim 1, which comprises the additional step of attaching a fluid communication means to the proximal end of the catheter piece to enable the first lumen to be in fluid communication with an inflation fluid source.

3. The method of claim 1, wherein the tubing blown in step (a) has more than two lumens.

4. The method of claim 3, wherein the tubing has at least one lumen having an open distal end.

5. The method of claim 4, which comprises the additional step of attaching fluid communication means to the proximal end of the catheter to enable the first lumen to be in fluid communication with an inflation fluid source and to enable at least one additional lumen to be in fluid communication with the proximal end of the catheter.

6. A method of preparing a balloon dilatation catheter which comprises the steps of:

(a) blowing a length of multiple lumen tubing to produce a double lumen catheter having distal and proximal ends and having first and second lumens having respective proximal and distal ends;

(b) sealing the distal end of the first lumen;

(c) inflating the first lumen to cause a dilatation balloon to form in the first lumen proximal to the distal end of the first lumen;

(d) cutting an opening in the second lumen proximal to the distal end of the catheter;

(e) inserting a pushing wire having distal and proximal ends into the second lumen through the proximal end of the catheter until the distal end of the pushing wire extends distally across the opening;

(f) inserting a piece of lubricious tubing having proximal and distal ends proximally into the second lumen through the distal end of the catheter so that the proximal end of the lubricious tubing overlaps the distal end of the pushing wire;

(g) heating the distal portion of the catheter to cause the distal portion of the second lumen to shrink slightly to cause the lubricous tubing to fixedly engage the distal end of the pushing wire, while the first lumen is pressurized to prevent shrinkage of the preformed dilatation balloon; and

(h) heating the remaining portion of the catheter to cause the second lumen to shrink around the pushing wire.

7. The method of claim 6, which comprises the additional step of attaching a fluid communication means to the proximal end of the catheter to enable the first lumen to be in fluid communication with an inflation fluid source.

8. The method of claim 6, wherein the tubing blown in step (a) has more than two lumens.

9. The method of claim 8, wherein the tubing has at least one lumen having an open distal end.

10. The method of claim 9, which comprises the additional step of attaching fluid communication means to the proximal end of the catheter to enable the first lumen to be in fluid communication with an inflation fluid source and to enable at least one additional lumen to be in fluid communication with the proximal end of the catheter.